The FDA Wholesale License: What It Is and Who Needs It The Food and Drug Administration (FDA) is responsible for regulating the distribution of drugs, medical devices, and other regulated products in the United States. Wholesale distributors who are involved in the distribution of these products are required by law to obtain an FDA Wholesale License . The FDA Wholesale License is a federal license that wholesale distributors must obtain to engage in the wholesale distribution of prescription drugs. It is designed to ensure that wholesale distributors are operating safely and responsibly and to prevent the distribution of counterfeit or adulterated drugs. Who Needs an FDA Wholesale License? According to the FDA, anyone who engages in the wholesale distribution of prescription drugs must have a Wholesale License. This includes manufacturers, repackagers, wholesale distributors, and third-party logistics providers (3PLs) who distribute prescription drugs. Additionally, wholesale distribu